IN8bio, Inc. (NASDAQ:INAB) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. The company's lead product candidates, INB-400, INB-200, and INB-100, are currently in various stages of clinical trials, showcasing the breadth and depth of its pipeline.
Business Overview
IN8bio was founded in 2016 and is headquartered in New York, New York. The company's core technology, known as the DeltEx platform, leverages the unique properties of gamma-delta T cells to develop innovative cell therapies. Gamma-delta T cells are a specialized population of T cells that possess the ability to intrinsically differentiate between healthy and diseased tissue, making them a promising target for cancer treatment.INB-400 and INB-200
The company's lead product candidate, INB-400, is currently in a Phase 2 clinical trial for the treatment of newly diagnosed glioblastoma (GBM). This trial is designed to expand on the positive results observed in the investigator-initiated Phase 1 trial, known as INB-200. IN8bio expects to provide clinical updates and long-term follow-up data from the INB-200 trial at medical meetings throughout 2024, starting with a presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024.INB-100
In addition, IN8bio is developing INB-100 for the treatment of patients with high-risk leukemias undergoing hematopoietic stem cell transplantation (HSCT). The company has completed the primary enrollment of the Phase 1 clinical trial for INB-100 and presented encouraging clinical data at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in April 2023 and the American Society of Hematology (ASH) Annual Meeting in December 2023. The company plans to expand the INB-100 trial by an additional ten patients at the recommended Phase 2 dose and present updated data at medical meetings in 2024, starting with the European Hematological Association Congress (EHA) in June 2024.Financial Overview
For the fiscal year ended December 31, 2023, IN8bio reported an annual net loss of $30.0 million, with no revenue generated. The company's annual operating cash flow was -$23.3 million, and its annual free cash flow was -$23.9 million. These financial results reflect the company's ongoing investment in the development of its product candidates and the expansion of its DeltEx platform.In the first quarter of 2024, IN8bio reported a net loss of $8.6 million, with no revenue generated. The company's operating cash flow for the quarter was -$7.9 million, and its free cash flow was -$8.0 million. These quarterly results are consistent with the company's focus on advancing its clinical programs and strengthening its research and development capabilities.
Liquidity
As of March 31, 2024, IN8bio had $13.0 million in cash, which the company expects will only fund its projected operating expenses and capital expenditure requirements into January 2025. To continue funding its operations, the company is exploring various financing options, including equity and/or debt offerings, as well as potential strategic collaborations and licensing arrangements.In November 2022, IN8bio filed a shelf registration statement on Form S-3 with the SEC, which permits the offering, issuance, and sale of up to $200 million of the company's securities, of which $50 million may be issued and sold pursuant to an at-the-market (ATM) program. Through May 2, 2024, the company has sold an aggregate of 856,624 shares of its common stock under the ATM program, resulting in net proceeds of approximately $1.0 million.
Additionally, the company may receive up to $14.8 million in aggregate proceeds if the holders of its outstanding Series A warrants exercise their warrants pursuant to the mandatory exercise feature, which is triggered upon the company's public announcement of INB-100 data for the 10 currently enrolled patients. Further, if not otherwise redeemed by the company, it may also receive aggregate proceeds of up to $17.7 million from the exercise of its outstanding Series B warrants.
Risks and Challenges
As a clinical-stage biopharmaceutical company, IN8bio faces several risks and challenges that are common in the industry. These include the inherent uncertainties of the drug development process, the potential for delays or setbacks in clinical trials, the need to obtain regulatory approvals for its product candidates, and the competition from other companies developing similar therapies.Additionally, the company's reliance on third-party manufacturers and suppliers for the production of its product candidates introduces supply chain risks that could impact the timely availability of materials and the consistency of product quality. The company also faces the challenge of scaling up its manufacturing capabilities to support the potential commercialization of its products, if approved.
Outlook and Conclusion
Despite the challenges, IN8bio's promising pipeline of gamma-delta T cell therapies and its innovative DeltEx platform position the company for potential long-term success. The company's focus on advancing its lead product candidates, INB-400, INB-200, and INB-100, through clinical trials and towards potential regulatory approvals is a key priority.Furthermore, the company's efforts to expand its research and development capabilities, strengthen its manufacturing processes, and explore strategic partnerships and collaborations could unlock additional growth opportunities. As IN8bio continues to execute on its strategic initiatives, investors will closely monitor the company's progress and the potential clinical and commercial success of its gamma-delta T cell therapy pipeline.